Speedel: Phase 3 trial shows SPP100 has promising efficacy in diabetic hypertension patients

By E. Janene Geiss

Philadelphia, June 13 - Speedel said Tuesday that phase 3 clinical data showed robust efficacy and a good safety profile for SPP100, or Rasilez, in the treatment of hypertension in diabetic patients.

The findings were presented by Novartis at the European Society of Hypertension meeting, according to a company news release.

The data demonstrated promising efficacy and safety profile of SPP100 as a monotherapy and in co-administration with ramipril, an ACE(2) inhibitor, officials said.

SPP100 is the first-in-class once-daily oral renin inhibitor that Speedel said it developed through phase 1 and 2 clinical trials before Novartis exercised its license-back option in 2002.

The Food and Drug Administration in April accepted for review Novartis' New Drug Application for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives.

The European Society of Hypertension meeting is the first time that this data on Rasilez has been presented in a scientific forum in Europe, officials said.

The data presented were from a clinical trial in 837 patients with diabetes and hypertension. Such patients are at an increased cardiovascular risk, and the American Diabetes Association recommends a lower blood pressure goal than patients with hypertension without diabetes, officials said. In order to achieve blood pressure targets, most patients require therapy with multiple antihypertensive therapies.

The use of SPP100 with the ACE inhibitor ramipril not only decreases blood pressure further than ramipril alone through its additive effects, but also shows sustained 24-hour blood pressure control in these patients, officials said.

Speedel said it believes that SPP100 has a five-year lead over the next generation of renin inhibitors being developed in the industry.

Speedel is a Basel, Switzerland, biopharmaceutical company.

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